| Primary Device ID | 08059224095745 |
| NIH Device Record Key | f04f7ee2-1d7c-4ffa-825f-48889aa43fb5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OT Equator-Sphero Block Normo |
| Version Model Number | IMPRESSION COPING TRANSFER EQ |
| Catalog Number | Z-EQ-ICT |
| Company DUNS | 439240722 |
| Company Name | RHEIN 83 SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08059224095745 [Primary] |
| EGG | Attachment, Precision, All |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08059224095745]
Moist Heat or Steam Sterilization
[08059224095745]
Moist Heat or Steam Sterilization
[08059224095745]
Moist Heat or Steam Sterilization
[08059224095745]
Moist Heat or Steam Sterilization
[08059224095745]
Moist Heat or Steam Sterilization
[08059224095745]
Moist Heat or Steam Sterilization
[08059224095745]
Moist Heat or Steam Sterilization
[08059224095745]
Moist Heat or Steam Sterilization
[08059224095745]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-20 |
| Device Publish Date | 2024-11-12 |
| 08059224107844 | Sterilizable device for the dental impression. |
| 08059224095745 | Sterilizable device for the dental impression. |